佰仁医疗(688198.SH)：卵圆孔未闭封堵器注册申请获得受理

Group 1 - The core point of the article is that Baijun Medical (688198.SH) has had its registration application for the patent foramen ovale (PFO) occluder officially accepted by the National Medical Products Administration, which is a significant step in the development of interventional devices for structural heart disease [1] - The PFO occluder is designed to treat patients with a patent foramen ovale through catheter-based closure, potentially providing a cure for this condition [1] - The product is a self-expanding mushroom-shaped implant made from nickel-titanium alloy wire, lined with a PET polyester membrane, which maintains its shape at 37°C and effectively closes the abnormal shunt when implanted [1] Group 2 - The company has accumulated over a decade of experience in the research and clinical application of congenital heart disease occluders, which supports the development of the PFO occluder [1] - Preclinical studies and clinical trials have confirmed that the product meets safety and efficacy requirements for clinical use [1]